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| Product NDC Code | 50844-348 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Laxative maximum strength |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | ORAL | ||||||
| Dosage Form | TABLET, SUGAR COATED | ||||||
| RxCUI drug identifier | 251292 | ||||||
| Application Number | 505G(a)(3) | ||||||
| Labeler Name | L.N.K. International, Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient (in each tablet) Sennosides USP, 25 mg
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions swallow tablet(s) with a glass of water swallow tablet(s) whole; do not crush, break, or chew adults and children 12 years and over 2 tablets once or twice daily children 6 to under 12 years 1 tablet once or twice daily children under 6 years ask a doctor
| adults and children 12 years and over | 2 tablets once or twice daily |
| children 6 to under 12 years | 1 tablet once or twice daily |
| children under 6 years | ask a doctor |
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients acacia, calcium carbonate, carnauba wax, corn starch, dibasic calcium phosphate dihydrate, FD&C blue #1 aluminum lake, iron oxide black, magnesium stearate, methylparaben, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, povidone, propylene glycol, propylparaben, shellac glaze, silicon dioxide, sodium benzoate, sodium lauryl sulfate, sucrose, talc, titanium dioxide
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses relieves occasional constipation (irregularity) generally produces bowel movement in 6 to 12 hours
Purpose
Information about the drug product’s indications for use.Purpose Stimulant laxative
Spl product data elements
Usually a list of ingredients in a drug product.Laxative Maximum Strength Sennosides SENNOSIDES SENNOSIDES ACACIA CALCIUM CARBONATE CARNAUBA WAX STARCH, CORN DIBASIC CALCIUM PHOSPHATE DIHYDRATE FD&C BLUE NO. 1 ALUMINUM LAKE FERROSOFERRIC OXIDE MAGNESIUM STEARATE METHYLPARABEN MICROCRYSTALLINE CELLULOSE POLYETHYLENE GLYCOL, UNSPECIFIED POLYVINYL ALCOHOL, UNSPECIFIED POVIDONE, UNSPECIFIED PROPYLENE GLYCOL PROPYLPARABEN SHELLAC SILICON DIOXIDE SODIUM BENZOATE SODIUM LAURYL SULFATE SUCROSE TALC TITANIUM DIOXIDE 44;348
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel QUALITY +PLUS NDC 50844-348-08 *Compare to active ingredient in ex•lax ® Maximum Strength MAXIMUM STRENGTH LAXATIVE Sennosides USP, 25 mg Stimulant Laxative Gentle, Dependable Constipation Relief 24 Coated Tablets ACTUAL SIZE TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING Distributed by LNK INTERNATIONAL, INC. 60 Arkay Drive Hauppauge, NY 11788 USA *This product is not manufactured or distributed by GSK Consumer Healthcare S.A., owner of the registered trademark ex•lax ® Maximum Strength. 50844 ORG041934808 Quality Plus 44-348 Quality Plus 44-348
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks.
Ask doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs.
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor.
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions or comments? 1-800-426-9391
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, do not use for a period longer than 1 week.
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Storage and handling
Information about safe storage and handling of the drug product.Other information each tablet contains: calcium 40 mg, magnesium 5 mg TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25ºC (77ºF); excursions permitted between 15º-30ºC (59º-86ºF) see end flap for expiration date and lot number
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.Warnings Do not use laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor. Ask a doctor before use if you have noticed a sudden change in bowel habits that persists over a period of 2 weeks. Ask a doctor or pharmacist before use if you are taking any other drug. Laxatives may affect how other drugs work. Take this product 2 or more hours before or after other drugs. When using this product, do not use for a period longer than 1 week. Stop use and ask a doctor if rectal bleeding or failure to have a bowel movement occur after use of a laxative. These may be signs of a serious condition. If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API